Effect of Spironolactone on the Progression of Coronary Calcification in Peritoneal Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Relative progression of the coronary calcium score
研究概览
简要总结
Vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. Its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. There is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.The aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary calcium score > 30 Agatston unit
- •Peritoneal dialysis for at least 6 months
排除标准
- •Use of spironolactone in the last 3 months
- •Mean serum potassium > 6 mEq/L in the last 3 months
- •Cardiac revascularization surgeries
- •Arrhythmias
- •Pregnancy
研究组 & 干预措施
Spironolactone group
Spironolactone oral tablet 25mg/day, for 12 months
干预措施: Spironolactone 25Mg Tablet (Drug)
结局指标
主要结局
Relative progression of the coronary calcium score
时间窗: 12 months
Percentage change in coronary calcium score from baseline to end of study. Coronary calcium score detected using multi-detector computed tomography and expressed in Agatston units.
次要结局
- Absolute progression of the coronary calcium score(12 months)
- Adverse effects of spironolactone use(12 months)
- 1 year change in laboratory parameters of mineral metabolism(12 months)
- Need for spironolactone dose reduction(12 months)
- Causes of discontinuation of the study(12 months)
- 1 year change in laboratory parameters related to inflammation.(12 months)
研究者
Alex Sandro Rolland de Souza
Professor
Professor Fernando Figueira Integral Medicine Institute